Prelude IDeal™ Hydrophilic Sheath K21-00064

GUDID 10884450482954

Vascular catheter introduction set, nonimplantable

Primary Device ID	10884450482954
NIH Device Record Key	6ec2165b-a5ff-47ca-91fb-1bd806b5f8d2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Prelude IDeal™ Hydrophilic Sheath
Version Model Number	00884450482957
Catalog Number	K21-00064
Company DUNS	184763290
Company Name	Merit Medical Systems, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00884450482957 [Primary]
GS1	10884450482954 [Package] Contains: 00884450482957 Package: [5 Units] In Commercial Distribution
GS1	20884450482951 [Package] Package: [4 Units] In Commercial Distribution

OEX	Cardiovascular catheter sheath introducer kit

Steralize Prior To Use	false
Device Is Sterile	true